Company Visits
APVMA compliance officers make inspection visits to registrants’ premises to monitor records required under the Conditions of Registration.
Company visits are scheduled on the basis of information received at the APVMA including adverse experience reports, non-compliance reports, and previous failures in AgQA record keeping.
During these visits compliance officers review records for about 10 per cent of the range of registered products (that are subject to Conditions of Registration). For registrants with only a small number of products, officers will review records for at least one product.
The APVMA will give notice in writing of proposed company monitoring visits and will provide adequate time (minimum of 15 days) for the registrant to collate records for inspection during the visit. Records supplied after completion of the visit cannot be considered as part of the review.
At the beginning of the inspection visit Compliance Officers will explain the inspection process and give company representatives an opportunity to provide comment, seek clarification, and outline any occupational health and safety concerns at the site.
Once a review is completed the APVMA will notify the registrant in writing of any outcome and any compliance action resulting from non-compliance.
Where the records provided do not satisfy the Conditions of Registration, the APVMA will consider the nature of the failure, its significance and what risks the failure may present. Any enforcement action will reflect the significance of the failure and may include warning letters or the need for submission of applications to update particulars with the APVMA. In more significant matters the APVMA will consider product recall, testing orders, product suspension or prosecution.
The APVMA acknowledges that record monitoring visits pose significant demand on resources for registrants. To minimise the impact, these visits will be contained to a maximum of three days.
Registrants may rely on analytical method and related validation data previously submitted to the APVMA provided they have notified the APVMA prior to the inspection date. This notification must include the relevant APVMA file reference. It should also include:
- the analytical method number (if any) or title, OR
- the date of submission, OR
- the APVMA application number.
Where the information was provided by a third party, release from that party to access the information for the purpose of audit must be obtained.